Pelvic floor dysfunction UPDATE Whitney K. Hendrickson, MD Cindy L. Amundsen, MD Dr. Hendrickson is a Fellow in Female Pelvic Medicine Dr. Amundsen is the Roy T. Parker Professor in and Reconstructive Surgery, Department of Obstetrics Obstetrics and Gynecology, Urogynecology and and Gynecology, Division of Urogynecology, Duke Reconstructive Pelvic Surgery; Associate Professor University Health System, Durham, North Carolina. of Surgery, Division of Urology; Program Director of the Female Pelvic Medicine and Reconstructive Surgery Fellowship; Program Director of the K12 Multidisciplinary Urologic Research (KURe) Scholars Program; Program Director of the K12 BIRCWH Program, Duke University Medical Center, Durham, North Carolina. The authors report no financial relationships relevant to this article. Conservative to invasive approaches are available for treating women with fecal incontinence, but how do they stack up IN THIS in terms of efficacy and safety? Two experts review recent ARTICLE evidence on first- and second-line treatments, a vaginal Conservative FI bowel control system, and a sacral neuromodulation device. treatments page 24 ecal incontinence (FI), also known as or increased rectal sensation, or bowel inflam- accidental bowel leakage, is the invol- mation or dysfunction. Many conditions can Vaginal bowel 5,10,11 control system Funtary loss of feces, which includes cause FI (TABLE 1, page 24). It is therefore both liquid and solid stool as defined by the important to elicit a full medical history with page 27 International Continence Society (ICS) and a focus on specific bowel symptoms, such as the International Urogynecological Associa- stool consistency type (TABLE 2, page 26),12 Sacral tion (IUGA).1,2 Fecal incontinence is common, FI frequency, and duration of symptoms, as neuromodulation occurring in 7% to 25% of community-dwell- well as to perform a complete examination page 29 ing women, and it increases with age.2-6 The to identify any readily reversible or malignant condition is rarely addressed, with only causes. A colonoscopy is recommended for 30% of women seeking care.6-8 This is due individuals who meet screening criteria or to patient embarrassment and the lack of a present with a change in bowel symptoms, reliable screening tool. However, FI affects such as diarrhea, bleeding, or obstruction.13,14 quality of life and mental health, and the Fecal incontinence treatments include a associated economic burden likely will rise range of approaches categorized from conser- given the increased prevalence of FI among vative, or first-line therapy, to fourth-line sur- older women.2,4,7,9 gical managements (FIGURE 1, page 26).1,10,13,14 Fecal incontinence occurs due to poor In this Update, we review the results of stool consistency, anal and pelvic muscle 3 well-designed trials that enrolled women weakness, reduced rectal compliance, reduced with frequent nonneurogenic FI. CONTINUED ON PAGE 24 mdedge.com/obgyn Vol. 31 No. 9 | September 2019 | OBG Management 23 UPDATE pelvic floor dysfunction CONTINUED FROM PAGE 23 Common first- and second-line treatments produce equivalent improvements in FI symptoms at 6 months Jelovsek JE, Markland AD, Whitehead WE, et al; diversion, fecal impaction, neurologic dis- National Institute of Child Health and Human Devel- order leading to incontinence, use of lop- opment Pelvic Floor Disorders Network. Controlling eramide or diphenoxylate within the last 30 faecal incontinence in women by performing anal days, childbirth within the last 3 months, exercises with biofeedback or loperamide: a random- need for antiretroviral drugs, hepatic impair- ized clinical trial. Lancet Gastroenterol Hepatol. ment, or chronic abdominal pain without 2019;4:698-710. diarrhea. Baseline characteristics and symptoms n a multicenter, randomized trial of first- severity were similar among participants. The and second-line treatments for FI, Jelovsek average age of the women was 63 years, with I and colleagues evaluated the efficacy of 79% white and 85% postmenopausal. Par- oral placebo, loperamide, pelvic floor physi- ticipants had a mean (SD) of 1.6 (1.8) leaks cal therapy (PFPT) with biofeedback using per day. anorectal manometry, or combination ther- Participants were randomly assigned in apy over a 24-week period. a 0.5:1:1:1 fashion to receive oral placebo, loperamide, oral placebo with PFPT/biofeed- back, or loperamide with PFPT/biofeedback. Four treatments compared All participants received a standardized edu- Three hundred women with FI occurring cational pamphlet that outlined dietary and monthly for 3 months were included in the behavioral recommendations. trial. Women were excluded if they had a Women assigned to PFPT/biofeedback stool classification of type 1 or type 7 on the received 6 sessions every other week. Lop- Bristol Stool Scale, inflammatory bowel dis- eramide was started at a dosage of 2 mg per ease (IBD), history of rectovaginal fistula or day with the possibility of dose maintenance, cloacal defect, rectal prolapse, prior bowel escalation, reduction, or discontinuation. TABLE 1 Etiologies of fecal incontinence5,10,11 Gastrointestinal Anatomic Congenital Neurologic Risk factors Myopathy (scleroderma) Obstetric injury Imperforate anus Central nervous system Smoking Colitis or proctitis Surgical (fistulotomy, Spina bifida Dementia Obesity hemorrhoidectomy, sphincterotomy) Constipation Bowel resection Myelomeningocele Stroke Older age Rectal prolapse Rectocele Sciatica Physical disability Radiation Multiple sclerosis Inflammatory bowel disease Peripheral neuropathy (eg, diabetic) Irritable bowel syndrome Neoplasm Prior cholecystectomy Spinal cord lesions CONTINUED ON PAGE 26 24 OBG Management | September 2019 | Vol. 31 No. 9 mdedge.com/obgyn UPDATE pelvic floor dysfunction CONTINUED FROM PAGE 24 TABLE 2 Stool consistency classification by type All treatment groups according to the Bristol Stool Scale12 experienced improved FI symptoms Type Description Based on changes in Vaizey scores after 1 Separate hard lumps, like nuts (hard to pass) 24 weeks of treatment, women in all treat- 2 Sausage-shaped but lumpy ment groups had similar improvement in 3 Like a sausage but with cracks on the surface symptoms severity. However, those who 4 Like a sausage or snake, smooth and soft received loperamide and PFPT/biofeed- 5 Soft blobs with clear-cut edges back had decreased pad changes per week 6 Fluffy pieces with ragged edges, a mushy stool and more accident-free days compared with 7 Watery, no solid pieces; entirely liquid women treated with placebo and biofeed- back. Quality of life at 24 weeks was not sta- tistically different between treatment groups Study outcomes. The primary outcome as improvement was seen in all groups, was a change from baseline to 24 weeks in including those who received oral placebo the Vaizey FI symptom severity score, which and patient education. assesses fecal frequency, urgency, and Adverse events. The proportion of gas- use of pads and medications. Secondary trointestinal adverse effects was similar outcomes included assessment of a 7-day between treatment groups, ranging from bowel diary and other quality-of-life mea- 45% to 63%. Constipation was the most sures. Data at 24 weeks were available for common adverse event overall and was 89% of the women. more common in those taking loperamide, FIGURE 1 Treatment algorithm for fecal incontinence: Summary of society recommendations1,10,13,14 • Dietary modifications • Fiber supplementation 1st line • Antidiarrheal medication (loperamide, diphenoxylate with atropine, cholestyramine) • Physical therapy with biofeedback —Addition of biofeedback increases adequate relief from 41% to 77%15 • Anal plugs (cotton ball; Renew Inserts; Renew Medical Inc) 2nd line • Vaginal bowel control system (Eclipse System; Pelvalon) • Sacral nerve stimulation (InterStim; Medtronic) • Anal sphincteroplasty —If presence of EAS defect and < 10 years postpartum 3rd line • Correction of rectal prolapse, hemorrhoids, rectocele • Injectable anal sphincter bulking agents (NASHA-Dx) • Antegrade colonic enema 4th line • Colostomy Abbreviations: EAS, external anal sphincter; NASHA-Dx, non-animal stabilized hyaluronic acid–dextranomer. 26 OBG Management | September 2019 | Vol. 31 No. 9 mdedge.com/obgyn occurring in 51% of the loperamide plus WHAT THIS EVIDENCE MEANS FOR PRACTICE PFPT/biofeedback group, 38% of those who received loperamide alone, 23% of the bio- Women who suffer from frequent FI may require both loperamide and feedback with placebo group, and 12% of the PFPT/biofeedback if they want to increase the likelihood of accident- placebo-alone group. free days and use of fewer pads. Should they note increased consti- Strengths and limitations. Strengths of pation or are not amenable to scheduled PFPT sessions, formalized this study include its multisite, large sample education about dietary modifications, according to this study, will size, low dropout rate, and sufficiently pow- provide improvement in symptom severity. ered design to compare various combina- tions of first- and second-line therapies in women with a mean baseline FI of 1.6 leaks clinical use of this device is likely rare. Addi- per day. Another strength is the robustness tionally, the population was comprised of the PFPT/biofeedback sessions that used largely of postmenopausal and white women, anorectal manometry. This may, however, which may make the findings less generaliz- limit the study’s external validity given that able to other populations. Novel vaginal bowel